In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors that cannot be removed by surgery. Researchers want to find out if it is possible to use this new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.

Rate of technical success or failure to complete the initial procedure with no associated major complications. [ Time Frame: within 24 hours following the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Examination of the extent to which Visualase predictions based on MRTI data match lesion dimensions form post-therapy MRI assessments. [ Time Frame: Immediately following treatment (day 0) ] [ Designated as safety issue: No ]

Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure [ Time Frame: from day 0 to patient release ] [ Designated as safety issue: No ]

Local control of treated lesions as defined by volume of lesions increasing by no more than 25% [ Time Frame: Day 30, 90, and 180 days post procedure ] [ Designated as safety issue: No ]

Accrual of patient survival post Visualase therapy [ Time Frame: Sooner of 3 years or patient death ] [ Designated as safety issue: No ]

LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor

Detailed Description:

The Visualase Thermal Therapy System is FDA-cleared for thermal destruction of soft tissue in neurosurgery under MRI guidance. The device combines 3 previously FDA-cleared devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) to the tumor tissue; the PhoTex , Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment.

The Visualase Thermal Therapy System will be used in this study to give subjects a type of therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot.

Eligibility

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient or family able and willing to give informed consent.

Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy).

Three or fewer previously treated or untreated lesion(s) in the brain.

Tumor size ≤ 3.0 cm in largest diameter.

MR imaging is not contraindicated for the patient.

Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.

Able and willing to attend all study visits.

Karnofsky Performance Scale score >70 for patients over the age of 15.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00787982